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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02095691




Registration number
NCT02095691
Ethics application status
Date submitted
21/03/2014
Date registered
26/03/2014
Date last updated
7/12/2015

Titles & IDs
Public title
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
Scientific title
A Prospective, Multi-center, Non-Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II - 157)
Secondary ID [1] 0 0
RENABLATE-II
Universal Trial Number (UTN)
Trial acronym
RENABLATE-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Renal 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Celsius® ThermoCool® Renal Denervation

Experimental: Resistant Hypertension - The Celsius® ThermoCool® Renal Denervation catheter will serve to treat resistant hypertension.


Treatment: Devices: Celsius® ThermoCool® Renal Denervation
The investigational device is indicated for the treatment of resistant hypertension by renal denervation.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure. - Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.
Timepoint [1] 0 0
30 days post-procedure
Secondary outcome [1] 0 0
Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit - These adverse events include renal artery stenosis (=60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; =25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.
Timepoint [1] 0 0
12 months post-procedure
Secondary outcome [2] 0 0
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure - Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.
Timepoint [2] 0 0
12 months post-procedure
Secondary outcome [3] 0 0
Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure - The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.
Timepoint [3] 0 0
12 months post-procedure
Secondary outcome [4] 0 0
Incidence of Subjects Achieving a = 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure - Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.
Timepoint [4] 0 0
12 months post-procedure

Eligibility
Key inclusion criteria
1. Subject has a systolic blood pressure = 140 mmHg based on an average of 3 office blood
pressure readings measured according to the BP guidelines.

2. Subject is adhering to a stable drug regimen of at least 3 different classes of
anti-hypertensive medications, including a diuretic (with no changes for a minimum of
2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at
least 6 months.

3. Subject is > 18 and < 85 years of age.

4. Subject agrees to have all study procedures performed, and is competent and willing to
provide written, informed consent to participate in this study.

Key
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h
ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery
stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell
carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly,
Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum,
systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a
workup performed within the 12 months preceding enrollment.

2. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the
investigational device(s).

3. Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.

4. Subject has a prior history of any renal artery intervention including but not limited
to balloon angioplasty, stenting, renal denervation or surgery.

5. Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using
the MDRD formula.

6. Subject has type 1 diabetes mellitus.

7. Subject has history of Myocardial Infarction, unstable angina pectoris, or a
cerebrovascular accident in the 6 months period prior to enrolment, or documented
widespread atherosclerosis, intravascular thrombosis or unstable plaques.

8. Subject has hemodynamically significant valvular heart disease for which reduction of
blood pressure would be considered hazardous.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Prague
Country [2] 0 0
Italy
State/province [2] 0 0
Bari
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biosense Webster, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, multi-center, non-randomized, feasibility study to assess the safety
and effectiveness of renal artery sympathetic denervation using the investigational devices
in subjects with resistant hypertension.
Trial website
https://clinicaltrials.gov/show/NCT02095691
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications